Quality Engineer

Overview

The cGMP Quality Engineer is accountable for ensuring that radiopharmaceutical manufacturing processes, equipment, and facilities operate in sustained compliance with cGMP, regulatory requirements, and internal quality standards. This role provides quality oversight and governance for process validation, equipment qualification, and manufacturing operations, ensuring that validated and qualified states are properly documented, maintained, and defended. Working closely with Manufacturing, MSAT, and Quality Assurance, the Quality Engineer serves as the quality authority embedded in technical operations, enabling compliant execution while maintaining inspection readiness.

The role focuses on risk management, deviation control, and lifecycle quality assurance, rather than execution of validation or process design.

• Lead and own deviation investigations, root cause analysis, and the development and effectiveness of corrective and preventive actions (CAPA).
• Provide quality oversight for process validation, equipment qualification, aseptic processing, and cleanroom operations, ensuring adherence to approved protocols and regulatory expectations.
• Support site readiness activities including facility and cleanroom qualification, process startup, and introduction of new or modified manufacturing processes from a quality perspective.
• Review and approve GMP documentation, including protocols, reports, procedures, and technical change records, ensuring data integrity and compliance.
• Support internal, client, and regulatory audits and contribute quality input to regulatory submissions.
• Drive continuous improvement initiatives focused on compliance robustness, inspection readiness, and right-first-time manufacturing.
• Develop, implement, and maintain quality procedures, processes, and documentation in compliance with relevant industry regulations and standards (e.g., FDA, ISO, GMP, USP).
• Conduct internal audits and support external audits/inspections by clients and regulatory agencies.
• Participate in the management of the QMS, including document control, training, and record-keeping.
• Review and approve project documents, protocols, and reports related to process validation, equipment qualification, and test methodologies.
• Support validation activities for manufacturing processes, equipment, utilities, and clean rooms.
• Collaborate with Manufacturing, MSAT, and QA teams to maintain quality control measures on the production floor.
• Investigate and document quality issues, deviations, and non-conformances; support root cause analysis and corrective/preventive actions (CAPA).
• Lead investigations into quality issues, customer complaints, and non-conformities to identify root causes using systematic problem-solving methodologies.
• Track and trend quality data to identify recurring issues and opportunities for improvement.
• Review and approve incoming materials, supplier documentation and change controls as appropriate.
• Author, review, and approve regulated documents, including standard operating procedures (SOPs), test protocols, and reports.
• Assist in supplier qualifications and audits to ensure compliance with quality standards.
• Provide training and guidance to staff on quality assurance principles, and procedures.
• Maintain accurate, compliant records of quality processes, procedures, and activities.
• Ensure compliance with applicable quality and regulatory requirements (21 CFR 210/211/212, USP, EU GMP Annex 1 as applicable, and NRC, DOT Class
  7).
• Serve as SME during inspections and regulatory interactions.
• Select, commission, and validate radio synthesis platforms, hot cells, and automation systems, support training on new technologies.
• Oversee transfer documentation (URS, pRA, PQ) and deploy MES/e , LIMS, and quality-by-design solutions for data integrity and review-by-exception.
• Implement digital analytics to increase transparency and manufacturing efficiency.
• Partner with Supply Chain to secure consumables, spare parts, and critical materials.
• Apply ICH Q9 risk management to proactively address compliance and operational challenges.
• Drive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality.
• Ensure radiation safety and ALARA compliance in partnership with RSO and EHS.

• Bachelor’s degree in engineering (e.g., Chemical, Biomedical, Mechanical, Electrical), Chemistry, Life Sciences, or equivalent, or related field. A master’s degree or relevant certification (e.g., ASQ Certified Quality Engineer - CQE) is a plus.
• A minimum of 6 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry, preferably medical devices or pharmaceuticals. Experience with radiopharmaceuticals is highly desirable.

• Strong knowledge of cGMP regulations and pharmaceutical quality systems (e.g., FDA 21 CFR Parts 210/211, 820, Part 11 and Annex
  1).
• Familiarity with GxP, compliance and phase-appropriate validation…